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Potential outcome measures and trial design issues for multiple system atrophy.

Susanne May1, Sid Gilman, B Brooke Sowell

  • 1Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, California 92093-0717, USA. smay@ucsd.edu

Movement Disorders : Official Journal of the Movement Disorder Society
|October 5, 2007
PubMed
Summary

The Unified Multiple System Atrophy Rating Scale (UMSARS) is effective for tracking Multiple System Atrophy (MSA) progression in clinical trials. The UMSARS Motor Examination score is the most suitable outcome measure for therapeutic trials in MSA patients.

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Area of Science:

  • Neuroscience
  • Clinical Neurology
  • Medical Research Methodology

Background:

  • Multiple system atrophy (MSA) is a progressive neurodegenerative disorder characterized by parkinsonism, cerebellar ataxia, and autonomic dysfunction.
  • The Unified Multiple System Atrophy Rating Scale (UMSARS) is a validated tool for assessing MSA progression.
  • The utility of UMSARS as an outcome measure in therapeutic trials for MSA requires evaluation.

Purpose of the Study:

  • To evaluate the suitability of disease-specific scores, including UMSARS, as outcome measures for therapeutic trials in MSA.
  • To compare the performance of UMSARS-based scores with general health surveys like the SF-36.
  • To provide insights into trial design and sample size estimations for MSA studies.

Main Methods:

  • Analysis of 12-month follow-up data from an observational study of 67 patients with probable MSA.
  • Evaluation of three disease-specific scores: UMSARS Activities of Daily Living, UMSARS Motor Examination, and a combined UMSARS score.
  • Comparison with general health scores (SF-36 Physical and Mental Health) as potential outcome measures.

Main Results:

  • UMSARS-based scores demonstrated equal or superior performance compared to SF-36 scores in capturing disease progression.
  • UMSARS scores showed good correlation and required smaller sample sizes for therapeutic trials.
  • The UMSARS Motor Examination score emerged as the most favorable outcome measure for a 1-year follow-up therapeutic trial in MSA.

Conclusions:

  • Disease-specific measures, particularly the UMSARS, are highly effective for assessing Multiple System Atrophy progression in clinical research.
  • The UMSARS Motor Examination score is recommended as a primary outcome measure for therapeutic trials in MSA.
  • These findings support the use of UMSARS in designing efficient and sensitive clinical trials for MSA treatments.